NCT00531765已完成不适用
Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Incidence of Contrast Induced nephropathy
研究概览
简要总结
We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.
详细描述
We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (18 years and above) who are scheduled for cardiac catechization and have abnormal but stable renal function will be eligible for enrollment. Abnormal renal function is defined as a creatinine level exceeding the normal range (more than 115 or 96 um/L in males and females, respectively, in KFSH&RC laboratories) or eGFR less than 60 ml/min
排除标准
- •Patients who fall under any of the following categories will be excluded:
- •Acute renal failure
- •Cardiogenic shock
- •Emergency cardiac catheterization
- •Preexisting peritoneal or hemodialysis
- •Pregnancy
- •Recent exposure to contrast agent within the last 3 days
- •Allergy to contrast or any of the above treatment
- •Renal transplant,
- •Patients who received dopamine, mannitol, theophyllin or other medications known to affect renal function within one week from cardiac cath
- •Pulmonary edema / congestive heart failure
- •Use of N-acetylcystein
- •Patents on NSAIDS who can not stop using them for 48 hrs before and 48 hrs after procedure (except Aspirin).
结局指标
主要结局
Incidence of Contrast Induced nephropathy
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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